Evaluating the Effectiveness of a Community Exercise Program to Reduce the Risk of Metabolic Syndrome Among Black Americans

This study has been completed.

Sponsor:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00783445

First Posted: October 31, 2008

Last Update Posted: March 11, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Black Americans with a family history of early heart disease tend to have a group of risk factors that can contribute to heart disease. These risk factors, which include excess body weight, high blood pressure, and high cholesterol, are known collectively as metabolic syndrome. This study will compare a community-based, coach-led exercise program to an individual, self-led home-based exercise program to determine which program is more effective at reducing the metabolic syndrome risk factors that can lead to heart disease.

Participants will do 1 hour of exercise two to three times each week in a community setting for 1 year, while being supervised by a personal coach.

Active Comparator: 2

Self-exercise plan based on an individualized prescription after an initial fitness evaluation

Behavioral: Self-Help Exercise Program (HOME)

After a fitness evaluation, participants will be given an exercise prescription and recommendations for home-based, self-mediated progressive exercise. Participants will be expected to do 1 hour of exercise two to three times each week for 1 year.

Detailed Description:

Metabolic syndrome is a term that is used to describe a group of risk factors for coronary artery disease (CAD). The risk factors include abdominal obesity, insulin resistance, high cholesterol, and high blood pressure. People who live a sedentary lifestyle and do not get enough exercise are at risk of developing metabolic syndrome and CAD. Black Americans also have an increased risk of metabolic syndrome and CAD, particularly if they have a sibling younger than 60 years old who has premature CAD. Studies have shown that people who engage in regular, moderate intensity exercise can eliminate metabolic syndrome risk factors that can lead to CAD; however, many high-risk Black Americans do not take part in regular exercise. The purpose of this study is to compare a community-based, coach-led exercise program to an individual, self-led home-based exercise program to examine which program is more effective at reducing the metabolic syndrome risk factors that can lead to CAD in Black Americans.

This study will enroll Black Americans with metabolic syndrome who have a sibling with premature CAD. Participants will be randomly assigned (by individual) to either a community-based exercise program (C-FIT) or a self-help home-based exercise program (HOME). Participants in the C-FIT group will do 1 hour of exercise two to three times each week in a community setting and will be supervised by a personal coach or trainer for 1 year. Participants in the SELF group will undergo a fitness evaluation and will be instructed on how to exercise on their own. They also will be expected to do 1 hour of exercise two to three times each week for 1 year. Study visits will occur at baseline, Month 6, and Years 1 and 2. At all study visits, participants will undergo the following: a medical history review; physical examination; blood pressure measurements; blood collection; body measurements, including height, weight, and waist circumference; a treadmill stress test; a strength test; a dual-energy x-ray absorptiometry (DEXA) scan to measure body fat; an echocardiogram to examine the heart; a flow-mediated vasodilatation test for brachial reactivity to measure vascular function; and questionnaires on diet, exercise habits, and self-efficacy.

Eligibility

Information from the National Library of Medicine

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Already participating in regular exercise, defined as 90 minutes per week of activities of greater than 5 metabolic equivalents (METS)

Cardiac arrhythmias, including supraventricular tachycardia in the 5 years before study entry, any ventricular tachycardia, or greater than 4-beat runs of nonsustained premature ventricular contractions on baseline screening exercise testing

Body mass index (BMI) greater than 45 kg/m2

Alcohol or substance abuse in the 12 months before study entry

A known abnormal exercise electrocardiogram and an abnormal thallium scan (double abnormal), a moderate to severe defect on thallium scan, or a coronary calcium score greater than 500 on a prior screening

An abnormal exercise screening test supervised by a physician as part of this study

Pregnant

Current smokers if they have stated evidence of shortness of breath with normal exercises or a diagnosis of chronic obstructive pulmonary disease by their physician, as verified by medical records

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783445